IMPORTANT WARNING:

Blinatumomab injection should be given only under the supervision of a doctor with experience in the use of chemotherapy medications.

Blinatumomab injection may cause a serious, life-threatening reaction that may occur during infusion of this medication. Tell your doctor if you have ever had a reaction to blinatumomab or any other medication. You will receive certain medications to help prevent an allergic reaction before you receive each dose of blinatumomab. If you experience any of the following symptoms during or after receiving blinatumomab, tell your doctor immediately: fever, tiredness, weakness, dizziness, headache, nausea, vomiting, chills, rash, swelling of the face, wheezing, or difficulty breathing. If you experience a severe reaction, your doctor will stop your infusion and treat the symptoms of the reaction.

Blinatumomab injection may also cause serious, life-threatening central nervous system reactions. Tell your doctor if you have or have ever had seizures, confusion, loss of balance, or trouble speaking. If you experience any of the following symptoms, tell your doctor immediately: seizures, uncontrollable shaking of a part of the body, difficulty speaking, slurred speech, loss of consciousness, difficulty falling asleep or staying asleep, headache, confusion, or loss of balance.

Talk to your doctor about the risk(s) of using blinatumomab injection.

Why is this medication prescribed?

Blinatumomab is used in adults and children to treat certain types of acute lymphocytic leukemia (ALL; a type of cancer of the white blood cells) that has not gotten better, or that has returned after treatment with other medications. Blinatumomab is also used in adults and children to treat ALL that is in remission (a decrease or disappearance of signs and symptoms of cancer), but some evidence of the cancer remains. Blinatumomab is in a class of medications called bispecific T-cell engager antibodies. It works by slowing or stopping the growth of cancer cells in your body.

How should this medicine be used?

Blinatumomab comes as a powder to be mixed with liquid to be slowly injected intravenously (into a vein) by a doctor or nurse in a hospital or medical facility and sometimes at home. This medication is given continuously for 4 weeks followed by 2 to 8 weeks when the medication is not given. This treatment period is called a cycle, and the cycle may be repeated as necessary. The length of treatment depends on how you respond to the medication.

Your doctor may need to delay your treatment, change your dose, or stop your treatment if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment with blinatumomab injection.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before receiving blinatumomab injection,

tell your doctor and pharmacist if you are allergic to blinatumomab, any other medications, benzyl alcohol. or any other ingredients in blinatumomab injection. Ask your pharmacist for a list of the ingredients.

tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: cyclosporine (Gengraf, Neoral, Sandimmune) or warfarin (Coumadin, Jantoven). Many other medications may also interact with blinatumomab, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

tell your doctor if you have an infection or if you have or have ever had an infection that keeps coming back. Also, tell your doctor if you have ever had radiation therapy to the brain or have received chemotherapy or have or have ever had liver disease.

tell your doctor if you are pregnant or plan to become pregnant. You will need to have a pregnancy test before you receive this medication. You should not become pregnant during your treatment with blinatumomab and for at least 2 days after your final dose. Talk to your doctor about types of birth control that will work for you. If you become pregnant while using blinatumomab, call your doctor. Blinatumomab may harm the fetus.

tell your doctor if you are breastfeeding. Do not breastfeed while receiving blinatumomab and for at least 2 days after your final dose.

you should know that blinatumomab injection may make you drowsy. Do not drive a car or operate machinery while you are receiving this medication.

do not have any vaccinations without talking to your doctor. Tell your doctor if you have received a vaccine within the past 2 weeks. After your final dose, your doctor will tell you when it is safe to receive a vaccine.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What side effects can this medication cause?

Blinatumomab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

constipation

diarrhea

weight gain

back, joint, or muscle pain

swelling of the arms, hands, feet, ankles, or lower legs

pain at the injection site

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

chest pain

numbness or tingling in the arms, legs, hands, or feet

shortness of breath

ongoing pain that begins in the stomach area but may spread to the back that may occur with or without nausea and vomiting

fever, sore throat, cough, and other signs of infection

Blinatumomab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

fever

uncontrollable shaking of a part of the body

headache

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before, during, and after your treatment to check your body's response to blinatumomab injection and to treat side effects before they become severe.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.